Granules India arm gets USFDA nod for generic version of Valcyte

Valganciclovir hydrochloride oral solution is bioequivalent to the reference listed drug product (RLD), Valcyte for Oral Solution, 50mg/mL, OF Roche Palo Alto LLC, Granules India said.

New Delhi: Drugmaker Granules India recently informed the bourses that it's wholly-owned subsidiary, Granules Pharmaceuticals, Inc. has received approval from the US health regulator for Valganciclovir hydrochloride oral solution, an antiviral medication.

"The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of Granules India Limited for Valganciclovir Hydrochloride for Oral Solution, 50MG/ML," Granules said in a BSE filing.

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It is bioequivalent to the reference listed drug product (RLD), Valcyte for Oral Solution, 50mg/mL, OF Roche Palo Alto LLC.

Valganciclovir Hydrochloride solution is an antiviral medication used to treat cytomegalovirus infections.

Formed in 1984 as Triton Laboratories, Granules India has seven manufacturing facilities; six are in India while the seventh is through a joint venture with Hubei Biocase in Wuhan, China. The company also has two research centres, at Hyderabad and Pune.

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